DiabetesBPLLvHbA1cNCT04442698
Tailored Bilio-Pancreatic Limb and HbA1c 10 Years Post Mini-Gastric Bypass
An observational study of Diabetes and Surgery, run by Kular Hospital at 1 site in India.
Trial summary
Diabetes is now or soon will be a worldwide epidemic. Diabetes has impact on both healthcare costs in addition to the costs in human lives, suffering and disability. Treatment that lowers Hemoglobin A1c (HbA1c) improved outcomes. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- What is being tested?
- Mini-Gastric Bypass Original Technique
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2008to 1 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients having undergone Mini-Gastric Bypass -Original Technique post operative patients
Who may be able to join
- Mini-Gastric Bypass -Original Technique post operative patients
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tailored Bilio-Pancreatic Limb Length and Hemoglobin A1c Levels 10 Years Following Mini-Gastric Bypass Original Technique
Diabetes is now or soon will be a worldwide epidemic. Diabetes has impact on both healthcare costs in addition to the costs in human lives, suffering and disability. Treatment that lowers Hemoglobin A1c (HbA1c) improved outcomes. Studies have demonstrated that both general surgery and bariatric procedures may improve or reverse diabetes. In several studies the Billroth II reconstruction following gastrectomy was the most effective surgical technique in improving or reversing Diabetes. The purpose of this study is to analyze the outcomes of the Mini-Gastric Bypass-Original Technique (MGB-OT) version of the One Anastomosis Bypass (OAGB) to investigate the association of a "Tailored" Bilio-pancreatic Limb Length (BPLL) with the HbA1c changes.
Read the detailed description
There is general agreement that Diabetes is now or soon will be a worldwide epidemic. Studies also make clear the devastating impact of diabetes on both healthcare costs in addition to the costs in human lives, suffering and disability. It is also clear that treatment that lowers Hemoglobin A1c (HbA1c) will result in improved outcomes proportional to the decrease, saving both lives and costs. Unfortunately medical and lifestyle therapy routinely result in less than ideal resolution of elevated HbA1c levels. Studies have demonstrated that both general surgery and bariatric procedures may improve or reverse diabetes. In several studies the Billroth II reconstruction following gastrectomy is the most effective surgical technique in improving or reversing Diabetes. The purpose of this study is to analyze the outcomes of the Mini-Gastric Bypass-Original Technique (MGB-OT) version of the One Anastomosis Bypass (OAGB) to investigate the association of a "Tailored" Bilio-pancreatic Limb Length (BPLL) with the HbA1c changes.
- Being tested
- Mini-Gastric Bypass Original Technique
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini-Gastric Bypass Original TechniqueProcedure or surgery
Also called One Anastomosis Bypass
Follow up of the Surgical procedure outcomes in diabetics. Procedure Mini-Gastric Bypass Original Technique
| Study group | Role | What they receive |
|---|---|---|
| Diabetic MGB post op patients | Diabetic MGB post op patients Receives: Procedure: Mini-Gastric Bypass Original Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c Levels (HbA1c)
HbA1c Levels
Measured: 10 years
Delta Hemoglobin A1c Levels (HbA1c)
Delta HbA1c from Before to After MGB-OT surgery
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Jan 2008
- Primary completion1 Jan 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kular Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Robert Rutledge, Kular Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442698
- Sponsor's protocol ID
- KularH
- Acronym
- BPLLvHbA1c
- Status last verified
- Jun 2020
- First submitted
- 19 Jun 2020
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Bilio-Pancreatic Limb Length and Hemoglobin A1c Levels 10 Years Following Mini-Gastric Bypass Original Technique
- ClinicalTrials.gov ID
- NCT04442698
- Acronym / sponsor ID
- BPLLvHbA1c / KularH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Kular HospitalUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetes is now or soon will be a worldwide epidemic. Diabetes has impact on both healthcare costs in addition to the costs in human lives, suffering and disability. Treatment that lowers Hemoglobin A1c (HbA1c) improved outcomes. Studies have demonstrated that both general surgery and bariatric procedures may improve or reverse diabetes. In several studies the Billroth II reconstruction following gastrectomy was the most effective surgical technique in improving or reversing Diabetes. The purpose of this study is to analyze the outcomes of the Mini-Gastric Bypass-Original Technique (MGB-OT) version of the One Anastomosis Bypass (OAGB) to investigate the association of a "Tailored" Bilio-pancreatic Limb Length (BPLL) with the HbA1c changes.
Detailed description
There is general agreement that Diabetes is now or soon will be a worldwide epidemic. Studies also make clear the devastating impact of diabetes on both healthcare costs in addition to the costs in human lives, suffering and disability. It is also clear that treatment that lowers Hemoglobin A1c (HbA1c) will result in improved outcomes proportional to the decrease, saving both lives and costs. Unfortunately medical and lifestyle therapy routinely result in less than ideal resolution of elevated HbA1c levels. Studies have demonstrated that both general surgery and bariatric procedures may improve or reverse diabetes. In several studies the Billroth II reconstruction following gastrectomy is the most effective surgical technique in improving or reversing Diabetes. The purpose of this study is to analyze the outcomes of the Mini-Gastric Bypass-Original Technique (MGB-OT) version of the One Anastomosis Bypass (OAGB) to investigate the association of a "Tailored" Bilio-pancreatic Limb Length (BPLL) with the HbA1c changes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic MGB post op patients | – | Procedure: Mini-Gastric Bypass Original TechniqueDiabetic MGB post op patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having undergone Mini-Gastric Bypass -Original Technique post operative patients
Key inclusion criteria (1 listed)
- Mini-Gastric Bypass -Original Technique post operative patients
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mini-Gastric Bypass Original TechniqueAlso: One Anastomosis BypassFollow up of the Surgical procedure outcomes in diabetics. Procedure Mini-Gastric Bypass Original Technique | Procedure or surgery | Diabetic MGB post op patients |
Primary outcome
Hemoglobin A1c Levels (HbA1c)
Time frame: 10 years
HbA1c Levels
Delta Hemoglobin A1c Levels (HbA1c)
Time frame: 10 years
Delta HbA1c from Before to After MGB-OT surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Surgery, run by Kular Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c Levels (HbA1c) (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2020.